Diltiazem Tablets

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (diltiazem tablets) affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Talk with your doctor before you drink alcohol.
• Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
• You may need to have an ECG checked before starting this medicine and while taking it. Talk with your doctor.
• If you are taking this medicine (diltiazem tablets) and have high blood pressure, talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
• If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
• This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine with your other drugs.
• If you are 65 or older, use this medicine (diltiazem tablets) with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Flushing.
• Headache.
• Upset stomach.
• Dizziness.
• Feeling tired or weak.
• Runny nose.
• Sore throat.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl), monohydrochloride, (+)-cis-. The structural formula is:

Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.99. Each tablet, for oral administration, contains 30 mg, 60 mg, 90 mg, or 120 mg diltiazem hydrochloride. In addition, each tablet contains the following inactive ingredients: ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, polyethylene glycol, and sodium lauryl sulfate.

For oral administration.

Diltiazem Hydrochloride Tablets, USP are available containing 30 mg, 60 mg, 90 mg or 120 mg of diltiazem hydrochloride, USP.

The 30 mg tablets are white, film-coated, round, unscored tablets debossed with M over 23 on one side of the tablet and blank on the other side. They are available as follows:

NDC 0378-0023-01
bottles of 100 tablets

NDC 0378-0023-05
bottles of 500 tablets

The 60 mg tablets are white, film-coated, round, tablets debossed with M over 45 on one side of the tablet and scored on the other side. They are available as follows:

NDC 0378-0045-01
bottles of 100 tablets

NDC 0378-0045-05
bottles of 500 tablets

The 90 mg tablets are white, film-coated, capsule-shaped tablets debossed with M135 on one side of the tablet and scored on the other side. They are available as follows:

NDC 0378-0135-01
bottles of 100 tablets

NDC 0378-0135-05
bottles of 500 tablets

The 120 mg tablets are white, film-coated, capsule-shaped tablets debossed with M525 on one side of the tablet and scored on the other side. They are available as follows:

NDC 0378-0525-01
bottles of 100 tablets

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Protect from light.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Revised: 1/2017
DILT:R12

NDC 0378-0023-01

Diltiazem
Hydrochloride
Tablets, USP
30 mg

Swallow tablets whole.
Do not split, crush or chew tablets.

Rx only       100 Tablets

Each film-coated tablet contains:
Diltiazem
hydrochloride, USP      30 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Protect from light.

Usual Dosage: See accompanying
prescribing information.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

RM0023A8

NDC 0378-0525-01

Diltiazem
Hydrochloride
Tablets, USP
120 mg

Swallow tablets whole.
Do not split, crush or chew tablets.

Rx only       100 Tablets

Each film-coated tablet contains:
Diltiazem
hydrochloride, USP      120 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Protect from light.

Usual Dosage: See accompanying
prescribing information.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

RM0525A7